FDA CVM Regulatory Managing Scientist

We are seeking an FDA CVM Regulatory Managing Scientist to work as part of a team providing high-level FDA CVM guidance, project management, technical expertise, and project support to consultants in the Chemical Regulation and Food Safety Practice. The role involves providing regulatory and technical strategy related to FDA CVM approval for new and generic animal drugs, authoring and submitting regulatory filings, and evaluating technical and regulatory information in support of FDA CVM submissions.

What You Will Do

The successful candidate will work on providing high-level regulatory and technical strategy, authoring and submitting regulatory filings, and evaluating technical and regulatory information in support of FDA CVM submissions. They will also engage directly with clients and regulators throughout the strategy development, application submission, and review process for new and generic drugs.

Why It Might Be a Fit

This role requires a strong ability to organize and prioritize multiple projects with competing deadlines, excellent oral and written communication skills, and experience with project management, budget tracking, and invoicing. The successful candidate will have a DVM (preferred), Ph.D., or Master's degree in a science-related field and five or more years of FDA CVM or FFDCA regulatory experience.

Requirements

• DVM (preferred), Ph.D., or Master's degree in a science-related field
• Five or more years of FDA CVM or FFDCA regulatory experience
• Consulting experience preferred (but not required)
• Excellent oral and written communication skills
• Ability to work independently and manage time effectively
• Strong ability to organize and prioritize multiple projects with competing deadlines
• Experience with project management, budget tracking, and invoicing a plus

Benefits

• Competitive salary
• Annual bonus
• 401(k) employer contribution of 7% of base salary
• Access to benefits information on the Life@Exponent page